Magnet-assisted device (Flexagon SFM plus OTOLoc) to join sections of the colon
Safety and Device Functionality of the Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating Ileo-colic, Colo-colonic and Colorectal Anastomoses in Patients Undergoing Surgical Procedures
This will try a magnet-based device (Flexagon 25mm SFM plus OTOLoc) to create side-to-side or end-to-side colorectal connections in adults having laparoscopic colon surgery for cancer or diverticular disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | GI Windows, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, prednisone |
| Locations | 1 site (Orlando, Florida) |
| Trial ID | NCT07276529 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-center, single-arm early feasibility study testing the Flexagon 25mm Self Forming Magnet (SFM) system plus OTOLoc to create side-to-side ileo-colic, colo-colonic and side-to-side or end-to-side colorectal anastomoses. Up to 3 roll-in (training) participants may be enrolled at centers without prior SFM experience, and a primary analysis cohort will include at least 17 participants. The primary endpoint is a composite safety/effectiveness measure defined as successful creation of the target anastomosis without procedure-, device- or anastomosis-related reoperation through 30 days. All procedures are performed under general anesthesia by trained surgeons, with follow-up at discharge, day 7, day 30, and day 60.
Who should consider this trial
Good fit: Adults aged 22 or older scheduled for laparoscopic right or left hemicolectomy, sigmoidectomy, or low anterior resection who meet medical clearance, live within 150 miles of the study center, and meet device-related eligibility criteria are ideal candidates.
Not a fit: Patients with obstructed or perforated colon cancer at screening, GI tract anomalies that prevent passage of the magnet, known allergy to device materials, uncontrolled diabetes, BMI over 55, or those not suitable for laparoscopic anastomosis are unlikely to benefit.
Why it matters
Potential benefit: If successful, the device could offer a less invasive way to form bowel connections that may reduce technical complexity and some procedure-related complications.
How similar studies have performed: Magnetic compression anastomosis techniques have shown promising results in small series, but use of this specific SFM plus OTOLoc system remains early and limited to feasibility evaluations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged 22 years or older at screening 2. Candidate for surgery requiring Right of Left Hemicolectomy or Sigmoidectomy or Low Anterior resection with cardiac/medical clearance for surgery 3. Able to understand and sign informed consent document 4. American Society of Anesthesiologists (ASA) score \< IV at time of procedure 5. All cancer patients must have completed chemotherapy ≥2 months prior to procedure 6. Lives, and intends to remain, within a 150-mile radius of study center for the duration of the study 7. Able to refrain from smoking during study follow-up period Exclusion Criteria: 1. Known or suspected allergy to silicone, nickel, titanium or Nitinol 2. BMI \> 55 kg/m2 3. Uncontrolled diabetes (defined as HbA1c \>10%) 4. Congenital or acquired anomalies of the GI tract, including atresia or malrotation that would inhibit passing of SFM magnet 5. Participants with an acute diagnosis of obstructed or perforated colon cancer at the time of the Screening Visit 6. Any documented conditions for which endoscopy and/or laparoscopy would be contraindicated or history of previous failed endoscopy that may suggest difficulty during endoscopic delivery of magnets 7. History of recurrent small bowel obstructions. 8. Coagulation deficiency not normalized by medical treatment or platelet count \<50,000/µL 9. Known moderate to severe renal disease (eGFR \< 44 milliliters per minute per 1.73m2) or ongoing dialysis 10. Hyperkalemia / hypercoagulability or prior Venus Thromboembolism / Pulmonary Embolism 11. Immunocompromised (e.g., active treatment for malignancies, hematologic malignancy, on immunosuppressive therapy, moderate or severe primary immunodeficiency, advanced or untreated HIV, active treatment with high-dose corticosteroids (i.e., 20 or more mg of prednisone or equivalent per day when administered for 2 or more weeks prior to surgery) or other immunosuppressive or immunomodulatory agents 12. Congestive heart failure with ejection fraction \<35% or clinically significant arrhythmia (any rhythm disturbances except sinus tachycardia, sinus bradycardia or a sinus rhythm with premature atrial or ventricular complexes) 13. Decompensated chronic obstructive lung disease 14. Active or suspected infection at the surgical site or a CDC Class 3/contaminated or Class 4/dirty-infected surgical wound. 15. Contraindication to general anesthesia 16. Breast-feeding, pregnant, or planning on becoming pregnant during the follow-up period 17. Currently participating or has participated in another clinical trial within the past 30 days and is receiving/has received an investigational drug, device, or biologic agent 18. Contraindication to general anesthesia 19. Participant is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator
Where this trial is running
Orlando, Florida
- Orlando Health — Orlando, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Peter J Lukin, BS
- Email: peter.lukin@giwindows.com
- Phone: 9787610183
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.